EP3705118A4 - Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung - Google Patents

Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung Download PDF

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Publication number
EP3705118A4
EP3705118A4 EP18872612.9A EP18872612A EP3705118A4 EP 3705118 A4 EP3705118 A4 EP 3705118A4 EP 18872612 A EP18872612 A EP 18872612A EP 3705118 A4 EP3705118 A4 EP 3705118A4
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EP
European Patent Office
Prior art keywords
preparation
dosage form
solid dosage
method therefor
oral solid
Prior art date
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Application number
EP18872612.9A
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English (en)
French (fr)
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EP3705118B1 (de
EP3705118A1 (de
Inventor
Sang Yeob Park
Hye Jung Lim
Jae Young Lee
Min Hyo Seo
Sa Won Lee
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Samyang Holdings Corp
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Samyang Holdings Corp
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Publication of EP3705118A4 publication Critical patent/EP3705118A4/de
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
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    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/366Lactones having six-membered rings, e.g. delta-lactones
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    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4025Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
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    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404Indoles, e.g. pindolol
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    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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    • A61K31/4412Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
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    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A61K9/0012Galenical forms characterised by the site of application
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    • A61K9/1605Excipients; Inactive ingredients
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    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP18872612.9A 2017-10-31 2018-10-30 Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung Active EP3705118B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20170144139 2017-10-31
PCT/KR2018/013034 WO2019088669A1 (ko) 2017-10-31 2018-10-30 붕해가 개선된 경구용 고형 제제 조성물 및 이의 제조 방법

Publications (3)

Publication Number Publication Date
EP3705118A1 EP3705118A1 (de) 2020-09-09
EP3705118A4 true EP3705118A4 (de) 2021-08-18
EP3705118B1 EP3705118B1 (de) 2024-02-14

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EP18872612.9A Active EP3705118B1 (de) 2017-10-31 2018-10-30 Zusammensetzung einer oralen festen darreichungsform mit verbesserter auflösung und verfahren zu ihrer herstellung

Country Status (5)

Country Link
US (1) US11980610B2 (de)
EP (1) EP3705118B1 (de)
JP (2) JP7458317B2 (de)
KR (3) KR102333609B1 (de)
WO (1) WO2019088669A1 (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11980610B2 (en) * 2017-10-31 2024-05-14 Samyang Holdings Corporation Oral solid dosage form composition having improved disintegration and preparation method therefor
WO2021155254A1 (en) 2020-01-31 2021-08-05 Nanocopoeia, Llc Amorphous nilotinib microparticles and uses thereof
IL297776A (en) 2020-04-30 2022-12-01 Nanocopoeia Llc Orally disintegrating tablets containing an amorphous solid dispersion of nalotinib
IT202000027678A1 (it) * 2020-11-18 2022-05-18 Indena Spa Dispersioni solide amorfe di cabozantinib-(s)-malato e processi per la loro preparazione
WO2022115464A1 (en) * 2020-11-25 2022-06-02 Nanocopoeia, Llc Amorphous cabozantinib particles and uses thereof
AU2021391823A1 (en) 2020-12-03 2023-06-29 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
CA3155855A1 (en) * 2020-12-07 2022-06-07 Tianjin Creatron Biotechnology Co., Ltd. Sorafenib pharmaceutical composition with high bioavailability and use thereof
WO2022177983A1 (en) * 2021-02-19 2022-08-25 Slayback Pharma Llc Pharmaceutical compositions of cabozantinib
JP2024516108A (ja) 2021-04-07 2024-04-12 バテル・メモリアル・インスティテュート 非ウイルス性担体を同定および使用するための迅速な設計、構築、試験、および学習技術
CN113069418A (zh) * 2021-04-21 2021-07-06 海南通用三洋药业有限公司 一种阿莫西林颗粒的制备方法
CN114306271B (zh) * 2021-11-24 2023-04-07 石药集团中奇制药技术(石家庄)有限公司 一种仑伐替尼组合物

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004006904A1 (en) * 2002-07-16 2004-01-22 Seoul Pharm. Co., Ltd. Oral controlled-release dosage forms containing acetaminophen
KR20090131584A (ko) * 2008-06-18 2009-12-29 한국콜마 주식회사 매스틱을 포함하는 발포성 속붕해정
CN102319251A (zh) * 2011-07-19 2012-01-18 淄博职业学院 阿司匹林双嘧达莫胃内漂浮胶囊及其制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW486370B (en) * 1996-12-25 2002-05-11 Yamanouchi Pharma Co Ltd Rapidly disintegrable pharmaceutical composition
WO2002069932A1 (fr) * 2001-03-05 2002-09-12 Nippon Shinyaku Co., Ltd. Compositions moussantes
CN101299993A (zh) * 2005-11-04 2008-11-05 伊士曼化工公司 用于给药难溶的药学活性剂的羧烷基纤维素酯
KR101381999B1 (ko) * 2007-07-06 2014-04-14 동아에스티 주식회사 위염 치료제의 효력을 극대화시키기 위한 가용화 위체류시스템 매트릭스 제제
AU2009224418B2 (en) 2008-03-11 2014-12-11 Aska Pharmaceutical Co., Ltd. Solid dispersion, pharmaceutical compositions containing the same, and processes for the production of both
WO2010064100A1 (en) 2008-12-04 2010-06-10 Intec Pharma Ltd. Baclofen gastroretentive drug delivery system
US20110071169A1 (en) * 2009-08-26 2011-03-24 Mai De Ltd Preparation of polymorphic form of lapatinib ditosylate
KR101257919B1 (ko) 2011-07-14 2013-04-30 주식회사 바이오파마티스 콜린 알포세레이트 또는 이의 약학적으로 허용되는 염을 포함하는 경구용 고형 제제 및 이의 제조방법
KR20130068291A (ko) * 2011-12-15 2013-06-26 주식회사 삼양바이오팜 이매티닙 유리염기를 포함하는 고체분산체 및 그의 제조방법
US11980610B2 (en) * 2017-10-31 2024-05-14 Samyang Holdings Corporation Oral solid dosage form composition having improved disintegration and preparation method therefor

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004006904A1 (en) * 2002-07-16 2004-01-22 Seoul Pharm. Co., Ltd. Oral controlled-release dosage forms containing acetaminophen
KR20090131584A (ko) * 2008-06-18 2009-12-29 한국콜마 주식회사 매스틱을 포함하는 발포성 속붕해정
CN102319251A (zh) * 2011-07-19 2012-01-18 淄博职业学院 阿司匹林双嘧达莫胃内漂浮胶囊及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
HUGHEY JUSTIN R ET AL: "The use of inorganic salts to improve the dissolution characteristics of tablets containing Soluplus -based solid dispersions", EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, ELSEVIER AMSTERDAM, NL, vol. 48, no. 4, 21 January 2013 (2013-01-21), pages 758 - 766, XP029000017, ISSN: 0928-0987, DOI: 10.1016/J.EJPS.2013.01.004 *

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US20200261426A1 (en) 2020-08-20
US11980610B2 (en) 2024-05-14
JP7458317B2 (ja) 2024-03-29
KR20210149002A (ko) 2021-12-08
KR20190049543A (ko) 2019-05-09
KR20230093401A (ko) 2023-06-27
EP3705118A1 (de) 2020-09-09
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WO2019088669A1 (ko) 2019-05-09

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